BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4121551 · Received July 29, 2014

    Report

    Report Number
    1049092-2014-00349
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CONVATEC, NIC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION, AS NONE OF THE DEVICES ATTEMPTED TO USE REACHED THE PT OR WERE INSERTED INTO PTS. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. PLEASE NOTE: THERE ARE THREE (3) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER TWO (2) CASES. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. REPORTED TO FDA ON JULY 28, 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN TESTING THE BALLOON PRIOR TO INSERTION, THE NURSE WAS UNABLE TO WITHDRAW THE WATER THAT WAS INITIATED INTO THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442691 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, NIC. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1